#validation processes

[compliance4all1]

ESSENTIALS OF VALIDATION – Do You Really Need It?

The essentials of validation planning, protocol writing, and change management will be explained.

[compliance4all1]

FDA Regulations for Analytical Instrument Qualification and Validation Processes

Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This webinar will help attendees understand the instrument qualification and system validation processes. Why Should You Attend: The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: Requirements and approaches for Analytical Instrument Qualification Risk based validation approach Going through the qualification phases User requirements, writing the specifications Testing and deviation handling Proper documentation Type and extend of qualification for USP Instrument Categories Periodic review and revalidation analytical instruments and equipment Wrap up - Final questions and answers Who Will Benefit: Laboratory managers, supervisors and analysts IT managers and staff Consultants Laboratory suppliers of material, equipment and services Senior quality managers Quality professionals Regulatory professionals Compliance professionals Production supervisors Validation engineers Manufacturing engineers Production engineers Design engineers Process owners Quality engineers Quality auditors Speaker Profile: Joy McElroy Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

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